Impact of Primary Letermovir Prophylaxis Versus Preemptive Antiviral Therapy for Cytomegalovirus on Economic and Clinical Outcomes after Hematopoietic Cell Transplantation.

Preemptive therapy (PET) historically has been the primary strategy to reduce early-onset cytomegalovirus (CMV) reactivation after allogeneic hematopoietic cell transplantation (HCT) but is associated with antiviral-associated toxicities and increases in healthcare resource utilization and cost. Despite its high cost, letermovir (LTV) prophylaxis has largely supplanted PET due to its effectiveness and tolerability. Direct comparisons between LTV and PET approaches on economic and clinical outcomes after allogeneic HCT remain limited. Objective: To compare total cost of care (inpatient and outpatient) between LTV prophylaxis and PET through day+180 after allogeneic HCT. Adult allogeneic CMV seropositive (R+) HCT recipients who initiated LTV <30 days after HCT between 01/01/18 and 12/31/18 were matched 1:1 to allogeneic CMV R+ HCT recipients between 01/01/15 and 12/31/17 (PET cohort). Patients were grouped into high-risk (HR) or standard-risk (SR) for CMV to compare the LTV and PET cohorts. Direct costs for each patient's index HCT admission and all subsequent inpatient and outpatient care through day+180 after HCT were determined and converted into 2021 US dollars and then to Medicare proportional dollars (MPD). A secondary analysis using 2019 average wholesale price was conducted to specifically evaluate anti-CMV medication costs. There were a total of 176 patients with 54 HR CMV pairs and 34 SR CMV pairs. No differences in survival between LTV and PET for both HR and SR CMV groups were observed. The rate of clinically significant CMV infection decreased for both HR CMV (11/54, 20.4% versus 38/54, 70.4%, P < .001) and SR CMV (1/34, 2.9% versus 12/34, 35.3%, P < .001) patients who were given LTV prophylaxis with corresponding reductions in val(ganciclovir) and foscarnet (HR CMV only) use. Among HR CMV patients, LTV prophylaxis was associated with reductions in CMV-related readmissions (3/54, 5.6% versus 18/54, 33.3%, P < .001) and outpatient visits within the first 100 days after HCT (20 versus 25, P = .002), and a decreased median total cost of care ($36,018 versus $75,525, P < .001) in MPD was observed. For SR CMV patients on LTV, a significant reduction in the median inpatient cost ($15,668 versus $27,818, P < .001) was found, but this finding was offset by a higher median outpatient cost ($26,145 versus $20,307, P = .030) that was not CMV-driven. LTV prophylaxis is highly effective in reducing clinically significant CMV reactivations for both HR and SR HCT recipients. In this study, LTV prophylaxis was associated with a decreased total cost of care for HR CMV patients through day+180. Specifically, reductions in CMV-related readmissions, exposure to CMV-directed antiviral agents, and outpatient visits in the first 100 days after HCT were observed. SR CMV patients receiving LTV prophylaxis benefited by having a reduced inpatient cost of care due to lowered room and pharmacy costs.

Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for Junior Faculty: One-Year Results of a Prospective Single Institution Initiative.

PURPOSE: Although mentorship has been associated with promotion, job satisfaction, and retention, data are limited on the mentorship experience of clinical- versus research-track physicians as well as feasibility and relative priority of formal program components. METHODS AND MATERIALS: Within a single-institution, multi-site, academic network, we implemented a Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for junior faculty. Validated surveys assessing mentee satisfaction were distributed at baseline and 1 year. The statistical analysis included Wilcoxon rank sum and signed tests. Mentees assessed the likelihood to recommend each program component (10-point Likert-type scale), and means with standard error (SE) are reported. RESULTS: Among 42 eligible junior faculty, 36 (86%) opted into the program. The median time since residency was 2.5 years (interquartile range, 1.75-5.25) on the clinical track (n = 12) and 3 years (interquartile range, 2.75-5.00) on the research track (n = 24). At baseline, research-track physicians reported higher satisfaction with mentoring than physicians on the clinical track (2.92 vs 2.16; P = .02). Among 32 physicians completing 1 year, overall satisfaction with mentoring increased compared with baseline (2.72 vs 3.87; P < .001), which persisted on subset analysis for both clinical- (2.16 vs 4.03; P < .001) and research-track physicians (2.99 vs 3.77; P = .005). At 1 year, 28 mentees (88%) opted to continue the program. Program components were rated 8.25 (SE, 0.37) for mentor-mentee pairings, 7.22 (SE, 0.39) for goal setting, 6.84 (SE, 0.47) for administrative support, 6.69 (SE, 0.44) for peer mentoring, and 6.53 (SE, 0.45) for steering committee oversight. Ratings of peer mentoring were not associated with track (P = .59) or years in practice (P = .29). CONCLUSIONS: Clinical-track physicians may be less satisfied with mentorship than research-track faculty. However, all junior faculty, regardless of track, appeared to benefit from formalizing dyadic mentor-mentee relationships, goal setting, and peer mentoring. Further work is needed to determine the role of mentorship in addressing physician burnout.

Attitudes and access to resources and strategies to improve quality of radiotherapy among US radiation oncologists: A mixed methods study.

INTRODUCTION: We aimed to assess contouring-related practices among US radiation oncologists and explore how access to and use of resources and quality improvement strategies vary based on individual- and organization-level factors. METHODS: We conducted a mixed methods study with a sequential explanatory design. Surveys were emailed to a random 10% sample of practicing US radiation oncologists. Participating physicians were invited to a semi-structured interview. Kruskal-Wallis and Wilcoxon rank-sum tests and a multivariable regression model were used to evaluate associations. Interview data were coded using thematic content analysis. RESULTS: Survey overall response rate was 24%, and subsequent completion rate was 97%. Contouring-related questions arise in ≥50% of clinical cases among 73% of respondents. Resources accessed first include published atlases (75%) followed by consulting another radiation oncologist (60%). Generalists access consensus guidelines more often than disease-site specialists (P = 0.04), while eContour.org is more often used by generalists (OR 4.3, 95% CI 1.2-14.8) and younger physicians (OR 1.33 for each 5-year increase, 95% CI 1.08-1.67). Common physician-reported barriers to optimizing contour quality are time constraints (58%) and lack of access to disease-site specialists (21%). Forty percent (40%, n = 14) of physicians without access to disease-site specialists indicated it could facilitate the adoption of new treatments. Almost all (97%) respondents have formal peer review, but only 43% have contour-specific review, which is more common in academic centres (P = 0.02). CONCLUSION: Potential opportunities to improve radiation contour quality include improved access to disease-site specialists and contour-specific peer review. Physician time must be considered when designing new strategies.

Safety of opioid prescribing among older cancer survivors.

BACKGROUND: Cancer survivors receive more long-term opioid therapy (LTOT) than people without cancer, but the safety of LTOT prescribing is unknown. METHODS: Opioid-naive adults aged ≥66 years who had been diagnosed in 2008-2015 with breast, lung, head and neck, or colorectal cancer were identified with data from Surveillance, Epidemiology, and End Results cancer registries linked with Medicare claims. Survivors with 1 or more LTOT episodes (≥90 consecutive days) occurring ≥1 year after their cancer diagnosis and before censoring at hospice entry, another cancer diagnosis, 6 months before death, or December 2016 were included. The safety of prescribing during the first 90 days of the first LTOT episode was measured during follow-up. As a positive safety indicator, the proportion of survivors with concurrent nonopioid pain management was measured. Indicators of less safe prescribing were the proportion of survivors with a high average daily opioid dose (≥90 morphine milligram equivalents) and the proportion of survivors with concurrent benzodiazepine dispensing. Multivariable logistic regression analyses were conducted to identify clinical predictors of each safety outcome. RESULTS: In all, 3628 cancer survivors received LTOT during follow-up (median duration, 4.9 months; interquartile range, 3.5-8.0 months). Seventy-two percent of the survivors received multimodal pain management concurrently with LTOT. Eight percent of the survivors had high-dose opioid prescriptions; 25% of the survivors received benzodiazepines during LTOT. Multivariable analyses identified variations in safety measures by multiple clinical factors, although none were consistently significant across outcomes. CONCLUSIONS: To improve safe LTOT prescribing for survivors, efforts should focus on increasing multimodal pain management and reducing inappropriate benzodiazepine prescribing. Different clinical predictors of each outcome suggest different drivers of safe prescribing.

Evaluating the Validity of the Clavien-Dindo Classification in Colectomy Studies: A 90-Day Cost of Care Analysis.

BACKGROUND: The Clavien-Dindo classification is widely used to report postoperative morbidity but may underestimate the severity of colectomy complications. OBJECTIVE: The purpose of this study was to assess how well the Clavien-Dindo classification represents the severity of all grades of complications after colectomy using cost of care modeling. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at a comprehensive cancer center. PATIENTS: Consecutive patients (N = 1807) undergoing elective colon or rectal resections without a stoma performed at Memorial Sloan Kettering Cancer Center between 2009 and 2014 who were followed up for ≥90 days, were not transferred to other hospitals, and did not receive intraperitoneal chemotherapy were included in the study. MAIN OUTCOME MEASURES: Complication severity was measured by the highest-grade complication per patient and attributable outpatient and inpatient costs. Associations were evaluated between patient complication grade and cost during 3 time periods: the 90 days after surgery, index admission, and postdischarge (<90 d). RESULTS: Of the 1807 patients (median age = 62 y), 779 (43%) had a complication; 80% of these patients had only grade 1 or 2 complications. Increasing patient complication grade correlated with 90-day cost, driven by inpatient cost differences (p < 0.001). For grade 1 and 2 patients, most costs were incurred after discharge and were the same between these grade categories. Among patients with a single complication (52%), there was no difference in index hospitalization, postdischarge, or total 90-day costs between grade 1 and 2 categories. LIMITATIONS: The study was limited by its retrospective design and generalizability. CONCLUSIONS: The Clavien-Dindo classification correlates well with 90-day costs, driven largely by inpatient resource use. Clavien-Dindo does not discriminate well among patients with low-grade complications in terms of their substantial postdischarge costs. These patients represent 80% of patients with a complication after colectomy. Examining the long-term burden associated with complications can help refine the Clavien-Dindo classification for use in colectomy studies. See Video Abstract at http://links.lww.com/DCR/B521. EVALUACIN DE LA VALIDEZ DE LA CLASIFICACIN DE CLAVIENDINDO EN ESTUDIOS DE COLECTOMA ANLISIS DEL COSTO DE LA ATENCIN EN DAS: ANTECEDENTES:La clasificación de Clavien-Dindo es utilizada ampliamante para conocer la morbilidad posoperatoria, pero puede subestimar la gravedad de las complicaciones de la colectomía.OBJETIVO:Evaluar que tan bien representa la clasificación de Clavien-Dindo la gravedad de todos los grados de complicaciones después de la colectomía utilizando un modelo de costo de la atención.DISEÑO:Estudio de cohorte retrospectivo.ENTORNO CLÍNICO:Centro oncológico integral.PACIENTES:Pacientes consecutivos (n = 1807) sometidos a resecciones electivas de colon o recto sin estoma realizadas en el Memorial Sloan Kettering Cancer Center entre 2009 y 2014 que fueron seguidos durante ≥ 90 días, no fueron transferidos a otros hospitales y no recibieron quimioterapia intraperitoneal.PRINCIPALES MEDIDAS DE VALORACION:Gravedad de la complicación medida por la complicación de mayor grado por paciente y los costos atribuibles para pacientes ambulatorios y hospitalizados. Se evaluó la asociación entre el grado de complicación del paciente y el costo durante 3 períodos de tiempo: posterior a la cirugía (hasta 90 días), a su ingreso y posterior al egreso (hasta 90 días).RESULTADOS:De los 1807 pacientes (mediana de edad de 62 años), 779 (43%) tuvieron una complicación; El 80% de estos pacientes tuvieron solo complicaciones de grado 1 o 2. El aumento del grado de complicación del paciente se correlacionó con el costo a 90 días, impulsado por las diferencias en el costo de los pacientes hospitalizados (p <0,001). Para los pacientes de grado 1 y 2, la mayoría de los costos se incurrieron después del alta y fueron los mismos entre ambas categorías. Entre los pacientes con una sola complicación (52%), no hubo diferencia en el índice de hospitalización, posterior al alta o en el costo total de 90 días entre las categorías de grado 1 y 2.LIMITACIONES:Diseño retrospectivo, generalizabilidad.CONCLUSIONES:La clasificación de Clavien-Dindo se correlaciona bien con los costos a 90 días, impulsados en gran parte por la utilización de recursos de pacientes hospitalizados. Clavien-Dindo no discrimina entre los pacientes con complicaciones de bajo grado en términos de sus costos sustanciales posterior al alta. Estos pacientes representan el 80% de los pacientes aquellos con una complicación tras la colectomía. Examinar la carga a largo plazo asociada a las complicaciones puede ayudar a mejorar la clasificación de Clavien-Dindo para su uso en estudios de colectomía. Consulte Video Resumen en http://links.lww.com/DCR/B521.

Association between Site-of-Care and the Cost and Modality of Radiotherapy for Prostate Cancer: Analysis of Medicare Beneficiaries from 2015 to 2017.

Among 84,447 radiotherapy (RT) courses for Medicare beneficiaries age ≥ 65 with prostate cancer treated with external beam RT (EBRT), brachytherapy, or both, 42,608 (51%) were delivered in hospital-affiliated and 41,695 (49%) in freestanding facilities. Freestanding centers were less likely to use EBRT + brachytherapy than EBRT (OR 0.84 [95%CI 0.84-0.84]; p < .001). Treatment was more costly in freestanding centers (mean difference $2,597 [95%CI $2,475-2,719]; p < .001). Adjusting for modality and fractionation, RT in hospital-affiliated centers was more costly (mean difference $773 [95%CI $693-853]; p < .001). Freestanding centers utilized more expensive RT delivery, but factors unrelated to RT modality or fractionation rendered RT more costly at hospital-affiliated centers.

Are Financial Payments From the Pharmaceutical Industry Associated With Physician Prescribing? : A Systematic Review.

BACKGROUND: Financial payments from the drug industry to U.S. physicians are common. Payments may influence physicians' clinical decision making and drug prescribing. PURPOSE: To evaluate whether receipt of payments from the drug industry is associated with physician prescribing practices. DATA SOURCES: MEDLINE (Ovid), Embase, the Cochrane Library, Web of Science, and EconLit were searched without language restrictions. The search had no limiting start date and concluded on 16 September 2020. STUDY SELECTION: Studies that estimated the association between receipt of industry payments (exposure) and prescribing (outcome). DATA EXTRACTION: Pairs of reviewers extracted the primary analysis or analyses from each study and evaluated risk of bias (ROB). DATA SYNTHESIS: Thirty-six studies comprising 101 analyses were included. Most studies (n = 30) identified a positive association between payments and prescribing in all analyses; the remainder (n = 6) had a mix of positive and null findings. No study had only null findings. Of 101 individual analyses, 89 identified a positive association. Payments were associated with increased prescribing of the paying company's drug, increased prescribing costs, and increased prescribing of branded drugs. Nine studies assessed and found evidence of a temporal association; 25 assessed and found evidence of a dose-response relationship. LIMITATION: The design was observational, 21 of 36 studies had serious ROB, and publication bias was possible. CONCLUSION: The association between industry payments and physician prescribing was consistent across all studies that have evaluated this association. Findings regarding a temporal association and dose-response suggest a causal relationship. PRIMARY FUNDING SOURCE: National Cancer Institute.

Sentinel Lymph Node Biopsy for T1b Melanoma: Balancing Prognostic Value and Cost.

BACKGROUND: The purpose of this study is to report the additional prognostic information and cost associated with sentinel lymph node biopsy (SLNB) for patients with T1b melanoma. PATIENTS AND METHODS: An institutional database was queried for patients with T1b melanoma (0.8-1.0 mm or < 0.8 mm with ulceration) with at least 5 years of follow-up. Results of SLNB, completion lymphadenectomy (CLND), recurrence, and melanoma-specific survival (MSS) were assessed. Institutional costs of melanoma care were converted to Medicare proportional dollars. A Markov model was created to estimate long-term costs. RESULTS: Among the total 392 patients, 238 underwent SLNB. Median follow-up was 10.5 years. SLNB was positive in 19 patients (8.0%). Patients who underwent SLNB had higher 10-year nodal recurrence-free survival (98.6% vs. 91.2%, p < 0.001) but not MSS (94.4% vs. 93.2%, p = 0.55). Ulceration (HR 4.7, p = 0.022) and positive sentinel node (HR 11.5, p < 0.001) were associated with worse MSS. Estimates for 5-year costs reflect a fourfold increase in total costs of care associated with SLNB. However, a treatment plan that forgoes adjuvant therapy for resected stage IIIA melanoma but offers systemic therapy for a node-basin recurrence would nullify the additional cost of SLNB. CONCLUSIONS: SLNB is prognostic for T1b melanoma. Its impact on the overall cost of melanoma care is intimately tied to systemic therapy in the adjuvant and recurrent settings.

Comparison of Cancer Specific Outcomes following Minimally Invasive and Open Surgical Resection of Early Stage Kidney Cancer from a National Cancer Registry.

PURPOSE: With anecdotal observations of atypical recurrences following minimally invasive surgery and alongside new concerns following cervical cancer surgery, there is a need to evaluate cancer specific outcomes for minimally invasive kidney cancer surgery using national data. We evaluated cancer specific outcomes following minimally invasive surgery vs open surgery for early stage kidney cancer. MATERIALS AND METHODS: We performed a retrospective population based cohort study using data from the SEER (Surveillance, Epidemiology, and End Results) program linked with Medicare claims that included beneficiaries at least 66 years old diagnosed between 2004 and 2013 with early stage, nonurothelial kidney cancer who underwent surgical resection within a year of diagnosis. We compared overall survival, disease specific survival, rate of second kidney cancer surgery and rate of postoperative systemic cancer therapy based on whether surgery was minimally invasive surgery or an open resection. Multivariable regression was used to account for confounders. RESULTS: A total of 5,150 patients were included in analysis and 3,062 (59.5%) underwent minimally invasive surgery. On multivariable analysis minimally invasive surgery was not associated with differences in overall survival (HR 0.94, 95% CI 0.84-1.06) or disease specific survival (HR 0.96, 95% CI 0.83-1.11). Patients treated with minimally invasive surgery were more likely to receive systemic cancer therapy (HR 1.31, 95% CI 1.09-1.59). No difference in the rate of second surgery associated with surgical approach was observed. CONCLUSIONS: Use of minimally invasive surgery for early stage kidney cancer was not associated with differences in overall or disease specific survival, or the rate of second kidney cancer surgery. Patients treated with minimally invasive surgery received more postoperative systemic therapy, which could represent a disparate cancer specific outcome associated with minimally invasive surgery.

Higher clinical suspicion is needed for prompt diagnosis of esophageal adenocarcinoma in young patients.

BACKGROUND: Esophageal cancer is considered a disease of the elderly. Although the incidence of esophageal adenocarcinoma in young patients is increasing, current guidelines for endoscopic evaluation of gastroesophageal reflux disease and Barrett's esophagus include age as a cutoff. There is a paucity of data on the presentation and treatment of esophageal cancer in young patients. Most studies are limited by small sample sizes, and conflicting findings are reported regarding delayed diagnosis and survival compared with older patients. METHODS: A retrospective cohort study was performed using the National Cancer Database between 2004 and 2015. Patients with esophageal adenocarcinoma were divided into quartiles by age (18-57, 58-65, 66-74, 75+ years) for comparison. Clinicopathologic and treatment factors were compared between groups. RESULTS: A total of 101,596 patients were identified with esophageal cancer. The youngest patient group (18-57 years) had the highest rate of metastatic disease (34%). No difference in tumor differentiation was observed between age groups. Younger patient groups were more likely to undergo treatment despite advanced stage at diagnosis. Overall 5-year survival was better for younger patients with local disease, but the difference was less pronounced in locoregional and metastatic cases. CONCLUSIONS: In this study, young patients were more likely to have metastatic disease at diagnosis. Advanced stage in young patients may reflect the need for more aggressive clinical evaluation in high-risk young patients.

Risk for Clostridiodes difficile Infection among Older Adults with Cancer.

To assess whether risk for Clostridiodes difficile infection (CDI) is higher among older adults with cancer, we conducted a retrospective cohort study with a nested case-control analysis using population-based Surveillance, Epidemiology, and End Results-Medicare linked data for 2011. Among 93,566 Medicare beneficiaries, incident CDI and odds for acquiring CDI were higher among patients with than without cancer. Specifically, risk was significantly higher for those who had liquid tumors and higher for those who had recently diagnosed solid tumors and distant metastasis. These findings were independent of prior healthcare-associated exposure. This population-based assessment can be used to identify targets for prevention of CDI.

Assessment of the Value of Comorbidity Indices for Risk Adjustment in Colorectal Surgery Patients.

BACKGROUND AND PURPOSE: Comorbidity indices (CIs) are widely used in retrospective studies. We investigated the value of commonly used CIs in risk adjustment for postoperative complications after colorectal surgery. METHODS: Patients undergoing colectomy without stoma for colonic neoplasia at a single institution from 2009 to 2014 were included. Four CIs were calculated or obtained for each patient, using administrative data: Charlson-Deyo (CCI-D), Charlson-Romano (CCI-R), Elixhauser Comorbidity Score, and American Society of Anesthesiologists classification. Outcomes of interest in the 90-day postoperative period were any surgical complication, surgical site infection (SSI), Clavien-Dindo (CD) grade 3 or higher complication, anastomotic leak or abscess, and nonroutine discharge. Base models were created for each outcome based on significant bivariate associations. Logistic regression models were constructed for each outcome using base models alone, and each index as an additional covariate. Models were also compared using the DeLong and Clarke-Pearson method for receiver operating characteristic (ROC) curves, with the CCI-D as the reference. RESULTS: Overall, 1813 patients were included. Postoperative complications were reported in 756 (42%) patients. Only 9% of patients had a CD grade 3 or higher complication, and 22.8% of patients developed an SSI. Multivariable modeling showed equivalent performance of the base model and the base model augmented by the CIs for all outcomes. The ROC curves for the four indices were also similar. CONCLUSIONS: The inclusion of CIs added little to the base models, and all CIs performed similarly well. Our study suggests that CIs do not adequately risk-adjust for complications after colorectal surgery.

Impact of Clinical Specialty on Attitudes Regarding Overuse of Inpatient Laboratory Testing.

Routine laboratory testing is common among hospitalized patients, with associated harm. Attitudes toward testing and drivers across clinical specialties have not been described. We performed a cross-sectional study and anonymously surveyed inpatient clinicians (nurses, advanced practice providers, and physicians) at a tertiary cancer center regarding attitudes toward unnecessary laboratory testing and its drivers across clinical specialties. A total of 837 providers completed surveys (response rate 53%). Most respondents agreed with daily testing of hospitalized patients and that daily labs generally enhance safety, and those from pediatric and surgical specialties generally valued testing less than others. Participants most commonly indentified habit and institutional culture as important drivers of unnecessary testing. There were differences in other drivers across specialties, with pediatric clinicians identifying family pressure more commonly and fear of litigation less commonly compared to others. Future interventions to reduce unnecessary inpatient laboratory testing should acknowledge different attitudes based on specialty and tailor interventions accordingly.

Percutaneous Ablation Versus Partial and Radical Nephrectomy for T1a Renal Cancer: A Population-Based Analysis.

Background: Stage T1a renal cell carcinoma (RCC) (tumors <4 cm) is usually curable. Nephron-sparing partial nephrectomy (PN) has replaced radical nephrectomy (RN) as the standard of care for these tumors. Radical nephrectomy remains the first alternative treatment option, whereas percutaneous ablation (PA), a newer, nonsurgical treatment, is recommended less strongly because of the relative paucity of comparative PA data. Objective: To compare PA, PN, and RN outcomes. Design: Observational cohort analysis using inverse probability of treatment-weighted propensity scores. Setting: Population-based SEER (Surveillance, Epidemiology, and End Results) cancer registry data linked to Medicare claims. Patients: Persons aged 66 years or older who received treatment for T1a RCC between 2006 and 2011. Interventions: PA versus PN and RN. Measurements: RCC-specific and overall survival, 30- and 365-day postintervention complications. Results: 4310 patients were followed for a median of 52 months for overall survival and 42 months for RCC-specific survival. After PA versus PN, the 5-year RCC-specific survival rate was 95% (95% CI, 93% to 98%) versus 98% (CI, 96% to 99%); after PA versus RN, 96% (CI, 94% to 98%) versus 95% (CI, 93% to 96%). After PA versus PN, the 5-year overall survival rate was 77% (CI, 74% to 81%) versus 86% (CI, 84% to 88%); after PA versus RN, 74% (CI, 71% to 78%) versus 75% (CI, 73% to 77%). Cumulative rates of renal insufficiency 31 to 365 days after PA, PN, and RN were 11% (CI, 8% to 14%), 9% (CI, 8% to 10%), and 18% (CI, 17% to 20%), respectively. Rates of nonurologic complications within 30 days after PA, PN, and RN were 6% (CI, 4% to 9%), 29% (CI, 27% to 30%), and 30% (CI, 28% to 32%), respectively. Ten percent of patients in the PN group had intraoperative conversion to RN. Seven percent of patients in the PA group received additional PA within 1 year of treatment. Limitations: Analysis of observational data may have been affected by residual confounding by provider or from selection bias toward younger, healthier patients in the PN group. Findings from this older study population are probably less applicable to younger patients. Use of SEER-Medicare linked files prevented analysis of patients who received treatment after 2011, possibly reducing generalizability to the newest PA, PN, and RN techniques. Conclusion: For well-selected older adults with T1a RCC, PA may result in oncologic outcomes similar to those of RN, but with less long-term renal insufficiency and markedly fewer periprocedural complications. Compared with PN, PA may be associated with slightly shorter RCC-specific survival but fewer periprocedural complications. Primary Funding Source: Association of University Radiologists GE Radiology Research Academic Fellowship and Society of Interventional Radiology Foundation.

Delays in the Publication of Important Clinical Trial Findings in Oncology.

Importance: The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry. While prior analyses have noted a substantial lag in the reporting of final clinical study results, we sought to refine these observations through use of a novel starting point for the measurement of dissemination delays: the date of a corporate press release regarding a phase 3 study's results. Objective: To measure the length of time elapsed between when a sponsor had results of study findings they deemed important to announce, and when the medical community had access to them. Design and Setting: Covering the years 2011 through 2016, we measured the delay from when 8 large pharmaceutical companies issued a press release announcing completed analyses of phase 3 clinical trials in oncology, and the public sharing of those results either on ClinicalTrials.gov or in a peer-reviewed biomedical journal as found via PubMed or Google Scholar. Press releases announcing regulatory steps and presentation schedules for conferences were excluded, as were those announcing results from preclinical trials, follow-up analyses, and studies of supportive care therapies or various modes of infusion for the same therapy. Main Outcomes and Measures: Time to public dissemination of clinical trial data. Results: Of the 100 press releases in our sample, 70 (70%) reported positive results, but only 31 (31%) included the magnitude of study findings. Through the end of follow-up, 99 (99%) of press releases had an associated peer-reviewed publication, complete data posting to ClinicalTrials.gov, or both, with a median time to reporting of 300 days (95% CI, 263-348 days). Positive findings were reported more quickly than negative ones (median of 272; 95% CI, 211-318 days vs 407; 95% CI, 298-705 days; log-rank P < .001). Conclusions and Relevance: Even for the most pressing study findings, median publication delays approach 1 year. As publication delays hinder research progress and advancements in clinical care, policies that enable early preprint release or public posting of completed data analysis should be pursued.

Exploring the impact of income and race on survival for women with advanced ovarian cancer undergoing primary debulking surgery at a high-volume center.

OBJECTIVE: To evaluate patients with advanced ovarian cancer (OC) undergoing primary debulking surgery (PDS) at a high-volume center (HVC), to determine whether socio-demographic disparities in PDS outcome and overall survival (OS) were present. METHODS: All patients with stages IIIB-IV high-grade OC undergoing PDS at our institution from 1/2001-12/2013 were identified. Patients self-identified race/ethnicity as non-Hispanic White (NHW), non-Hispanic Black (NHB), Asian (A), or Hispanic (H). Income level for the entire cohort was estimated using the census-reported income level for each patient's zip code as a proxy for SES. Main outcome measures were PDS outcome and median OS. Cox proportional hazards model was used to examine differences in OS by racial/ethnic and income category, controlling for selected clinical factors. RESULTS: 963 patients were identified for analysis: 855 NHW; 43 A, 34H, 28 NHB, and 3 unknown. PDS outcome was not significantly different among NHB and H as compared to NHW. Compared to NHW, Asians were more likely to have >1cm residual (AOR 2.32, 95%CI 1.1-4.9, p=0.03). Median income for the entire cohort was $85,814 (range $10,926-$231,667). After adjusting for significant prognostic factors, there were no significant differences in PDS outcome between income groups (p=0.7281). Median OS was 55.1mos (95%CI 51.8-58.5) with no significant differences in OS between the income (p=0.628) or racial/ethnic (p=0.615) groups. CONCLUSION: Statistically significant socio-demographic disparities in PDS and survival outcomes were not observed among women with advanced OC treated at this HVC. Increased efforts are needed to centralize care to and increase the diversity of pts treated at HVCs.

Adjuvant chemotherapy in patients with operable granulosa cell tumors of the ovary: a surveillance, epidemiology, and end results cohort study.

Adjuvant chemotherapy is recommended for patients with resected high-risk adult granulosa cell tumors (GCT), although strong data to support this are lacking. The objective of this study was to assess the outcomes of GCT patients, with the specific focus on patients that received adjuvant chemotherapy with curative intent (stage I-III), reported in a large national cancer registry. Data from the Surveillance, Epidemiology, and End Results (SEER) database between 2000 and 2013 were used for analysis. Patient and disease characteristics were extracted and analyzed for association with administration of chemotherapy. Impact on disease-specific survival (DSS) was analyzed using log-rank test. A total of 739 patients with surgically treated adult GCT were identified. Median age was 51 years. 570 (77%) patients were stage I, 87 (12%) were stage II, and 82 (11%) were stage III. Adjuvant chemotherapy was administered to 176 (24%) patients. Young age, higher stage, and hysterectomy were associated with chemotherapy administration. Higher disease stage was associated with decreased five-year DSS (IA/B 98.5%, IC 95.1%, II 86.1%, III 83.5%, P < 0.01). Notably, administration of adjuvant chemotherapy was not associated with improved five-year DSS (P = 0.45) regardless of disease stage (stage IA/B: 96% with chemotherapy vs. 99% without chemotherapy; P = 0.64), (stage IC: 97% with chemotherapy vs. 94% without chemotherapy; P = 0.49), (stage II: 89% with chemotherapy vs. 83% without chemotherapy; P = 0.56), (stage III: 73% with chemotherapy vs. 93% without chemotherapy; P = 0.18). In this analysis, chemotherapy was not found to be associated with improved DSS of patients with operable disease regardless of stage, questioning the role for adjuvant chemotherapy in GCT.

Immune-related adverse events for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis.

OBJECTIVE: To evaluate rates of serious organ specific immune-related adverse events, general adverse events related to immune activation, and adverse events consistent with musculoskeletal problems for anti-programmed cell death 1 (PD-1) drugs overall and compared with control treatments. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, Cochrane Library, Web of Science, and Scopus searched to 16 March 2017 and combined with data from ClinicalTrials.gov. STUDY SELECTION: Eligible studies included primary clinical trial data on patients with cancer with recurrent or metastatic disease. DATA EXTRACTION: Three independent investigators extracted data on adverse events from ClinicalTrials.gov and the published studies. Risk of bias was assessed using the Cochrane tool by three independent investigators. RESULTS: 13 relevant studies were included; adverse event data were available on ClinicalTrials.gov for eight. Studies compared nivolumab (n=6), pembrolizumab (5), or atezolizumab (2) with chemotherapy (11), targeted drugs (1), or both (1). Serious organ specific immune-related adverse events were rare, but compared with standard treatment, rates of hypothyroidism (odds ratio 7.56, 95% confidence interval 4.53 to 12.61), pneumonitis (5.37, 2.73 to 10.56), colitis (2.88, 1.30 to 6.37), and hypophysitis (3.38, 1.02 to 11.08) were increased with anti-PD-1 drugs. Of the general adverse events related to immune activation, only the rate of rash (2.34, 2.73 to 10.56) increased. Incidence of fatigue (32%) and diarrhea (19%) were high but similar to control. Reporting of adverse events consistent with musculoskeletal problems was inconsistent; rates varied but were over 20% in some studies for arthraligia and back pain. CONCLUSIONS: Organ specific immune-related adverse events are uncommon with anti-PD-1 drugs but the risk is increased compared with control treatments. General adverse events related to immune activation are largely similar. Adverse events consistent with musculoskeletal problems are inconsistently reported but adverse events may be common.

Metastasectomy in older adults with urothelial carcinoma: Population-based analysis of use and outcomes.

BACKGROUND: Metastatic urothelial carcinoma of the bladder, ureter, or renal pelvis is a highly aggressive disease with poor outcomes. Even with platinum-based chemotherapy, the median overall survival is 15 months and the 5-year survival is only 15%. The role of metastasectomy in urothelial carcinoma is currently undefined. OBJECTIVE: To examine the use and outcomes of metastasectomy in older patients with urothelial carcinoma in a large population-based dataset. DESIGN, SETTING, AND PARTICIPANTS: We conducted a SEER-Medicare study, and from 70,648 urothelial carcinoma patients who met inclusion criteria, we identified 497 patients who had at least 1 metastasectomy during a median follow-up of 40 months. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary study endpoints were metastasectomy use, the length of stay for metastasectomy, complications, and overall survival following metastasectomy. Secondary outcomes included 30-day mortality and readmission rate following metastasectomy. RESULTS AND LIMITATIONS: We identified 497 patients meeting inclusion criteria who had at least 1 metastasectomy during the study period including 24 patients who had more than 1 procedure resulting in a total of 523 metastasectomies. The median overall survival after the first metastasectomy was 19 months (95% CI: 15-23; interquartile range: 4-74). In this selected patient population, over a third of patients were alive at 3 years. In the 476 patients who had evaluable discharge dates, the median length of stay after metastasectomy was 7 days (IQR: 4-12), and 10% of patients had at least 1 complication within 30 days of discharge. Thirty-day mortality after metastasectomy was 10% (n = 53/523) and was largely driven by the mortality associated with resections of urothelial cancer brain metastases. CONCLUSIONS: In well-selected patients with urothelial carcinoma with a reasonable life expectancy, resection of metastatic lesions is safe and is associated with long-term survival and potential cures.